Registration Dossier

Administrative data

Description of key information

In vitro Epiderm and Corrositex®: corrosive [BASF, 2014]

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Justification for data waiving:
other:
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
GLP compliance:
yes
Test material information:
Composition 1
Species:
other: in vitro
Strain:
other: in vitro
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µl
- Concentration (if solution): undiluted

Duration of treatment / exposure:
up to 4 hours or until break through
Observation period:
Test substance: 3 min to 4 hours or until break through
Negative control: 60 min
Positive control: continuosly until break through
Details on study design:
4 tests were performed for the test item, one test for the positive, negative ant eht color (blank) control.
The experimental design of this study consisted of a qualification screen with the CDS (to determine if a color change can be detected) and a categorization screen (to categorize weak acids/bases and strong acids/bases), which were performed as a pretest, and a definitive Corrositex® assay.
The Corrositex® assay was evaluated on the basis of the color change of the CDS. The time that a color change was observed was recorded manually and the break through times of the four replicates was used to determine the corrosive potential of the test substance. For the qualification screen, 150 μL of the test substance was added to the CDS screening tube. If the test substance failed to produce a color change in the CDS within one minute, the test substance could not be analyzed in this system, and no further testing was required. In addition, one vial was used for the PC, NC and for the color (blank) control, each. A membrane disc coated with the biobarrier matrix was placed into one vial containing the CDS and approximately 500 μL of the test substance was added onto the membrane disc. An electronic time clock was started with the application. The vial was observed for three minutes for any change in the CDS. If no color change was observed within three minutes, the remaining membranes were
treated with the test substance. An electronic time clock was started with each application. The vials were observed continuously for the first ten minutes. Thereafter the vials were observed for approximately ten minutes around the time points relevant for evaluation or until break through of the test substance occurred. The elapsed time between test-substance application and the first change in the indicator solution (i.e. barrier
penetration) was recorded.

Break through times of the test substance and the PC and NC

Test substance

Break Through Time [min:s]

Vail 1

Vail 2

Vail 3

Vail 4

Mean

13/0406-1

30:40

27:08

26:39

28:46

28:18

Controls:

 

PC:

Sodium hydroxide, solid

09:37

-

-

-

-

NC:

10% citric acid

NB

-

-

-

-

Based on the observed results and applying the evaluation criteria described it was concluded, that 3-Amino-butan-1-ol shows a corrosive potential in the Corrositex® - Skin Corrosion Test under the test conditions chosen. The mean break through time

determined in the in vitro membrane barrier test was 28 minutes and 18 seconds.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are no studies available for (R)-3 -Amino-butan-ol, only for the racemat 3-Amino-butan-1 -ol.

In vitro Skin Corrosion Test

The potential of 3-Amino-butan-1-ol to cause dermal corrosion was assessed by a single topical application of 500 μL of the test substance to the Corrositex® Biobarrier Membrane (Corrositex® assay) (OECD 435). In the main test four Corrositex® Biobarrier Membranes were treated with the test substance. The mean break through time of the test substance, determined in the actual Corrositex® assay, was 28 minutes and 18 seconds. Based on the observed results and applying the evaluation criteria it was concluded, that 3-Amino-butan-1-ol shows a corrosive potential in the Corrositex® - Skin Corrosion Test under the test conditions chosen. [BASF, 2014]

The potential of 3 -Amino-butan-1-ol of the skin corrosion/irritation potential was assessed by a single topical exposure of 50 μL of the test substance to the surface of a human reconstituted epidermis model (EpiDerm TM) for 3 minutes and 1 hour followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of the yellow, water-soluble MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide), present in cell mitochondria, into a blue formazan salt that is measured quantitatively after isopropanol - extraction from the tissues. The optical density of the extracts of test substance treated tissues is compared to negative control values from tissue treated with highly de-ionized water and is expressed as relative tissue viability.

The EpiDerm TM skin corrositivity/irritation test showed the following results: Corrosion test: Teh mean viability of the test -substance treated tissues determined after an exposure period of 3 minutes was 25 % and it was 11% after an exposure period of 1 hour. Based on the observed results it was concluded, that 3 -Amino-butan-1 -ol shows a skin corrosion potential in the EpiDerm TM skin corrosion test under the test conditions chosen. [BASF, 2014]


Justification for selection of skin irritation / corrosion endpoint:
GLP guideline study

Justification for selection of eye irritation endpoint:
As the product corrodes the skin, it can be expected to have a similar effect on the eyes also. Thus, (3R)-aminobutan-1-ol has to be classified with eye damage cat. 1 according to GHS. No further test are needed.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

EU classification according to Annex I of Directive 67/548/EEC: C, R34

According to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 subtance is classified as Cat. 1B Causes severe skin burns and eye damage.